Cardio-vascular Diseases Clinical Trial
Official title:
Anti Vitamin K Therapeutic Education With INR Self Measure Device Within Children From 0 to 18 Years
| NCT number | NCT01587053 |
| Other study ID # | 8745 |
| Secondary ID | |
| Status | Terminated |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 2012 |
| Est. completion date | February 2017 |
| Verified date | November 2020 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The purpose of this study is to measure the INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) of children benefiting from the AVK therapeutic education program.
| Status | Terminated |
| Enrollment | 57 |
| Est. completion date | February 2017 |
| Est. primary completion date | February 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 18 Years |
| Eligibility | Inclusion Criteria: - age from 0 to 18 years - AVK prescription - to accept participating to AVK therapeutic education program - informed consent form of parents or legal person Exclusion Criteria: - parents or legal person refusal to enter in the AVK therapeutic education |
| Country | Name | City | State |
|---|---|---|---|
| France | Pediatric and Congenital Cardiology and Pulmonology Department, Arnaud De Villeneuve University Hospital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
Abassi H, Bajolle F, Werner O, Auer A, Marquina A, Mura T, Lavastre K, Guillaumont S, Manna F, Auquier P, Bonnet D, Amedro P. Health-related quality of life correlates with time in therapeutic range in children on anticoagulants with International Normali — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | INR (International Normalized Ratio) time percentage in the target zone (TTR: time in therapeutic range) | up to 1 year | ||
| Secondary | Quality of life questionnaire | 2 years |